CE Mark Certification

A CE Mark certificate is needed in order to market a medical device in the EU. This certificate verifies that the product is safe and performs as intended. The ISO 10993-1 standard prescribes a process for designing, testing, and documenting the biological safety of a medical device product. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements, including:

  • A Biological Evaluation Plan to describe and justify your test strategy
  • The selection, screening, and characterisation of construction materials
  • Assistance in scientific advisory meetings with regulatory bodies
  • The selection of appropriate laboratories, review of protocols, and monitoring of tests according to the requirements in the ISO 10993-series
  • A toxicological risk assessment of results

Why choose us?

SAXOCON services for medical device manufacturers give you access to:

  • A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
  • Extensive experience in state-of-the-art safety evaluations according to international standards and regional regulatory guidelines
  • Safety evaluations based on proprietary information obtained from our world-wide network of materials suppliers
  • Smart, cost-effective test strategies that bring your products to market in a timely manner

Delivery

SAXOCON compiles all necessary documentation for the approval of your product in a Biological Evaluation Report.

Related Services

Reusable medical devices

AAMI TIR12 compliant cleaning procedures.

materials screening

Properly evaluate your materials.

Manage change

Stay ISO 13485 and 14971 compliant.

Surface Characterisation

PMT analysis for ISO 10993-19 compliance.